SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies

NCT05765396 | Active Not Recruiting

• 1 other identifier: C.2023.007
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate new non-invasive passive surveillance technologies, Level 42 AI imPulse™ Una and TOR devices for the detection of COVID-19, Flu, and/or RSV in asymptomatic and symptomatic individuals over age of 18 undergoing COVID-19, Flu, and/or RSV screening and testing at BAMC Ft Sam Houston, TX; with and without COVID-19, Flu, and/or RSV. The hypotheses are: (H1) The imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their usability between the devices. (H2) Identify if the imPulseTM Una and the imPulseTM TOR e-stethoscopes have at least a similar discriminative and detection ability among symptomatic and asymptomatic Respiratory Syncytial Virus (RSV), Influenza and Long COVID carriers versus those not infected compared to gold standard Rapid RSV and Flu Antigen Tests, or RT-PCR and molecular assays. We will operationalize and deploy both the imPulseTM Una and imPulseTM TOR e-stethoscope into DoD use-cases and compare their captured traces in the early identification of disease/illness analyzed by the devices built in algorithms. (H3) In the mid to long-term, this approach will also be explored as a diagnostic system to explore pursue the physical (structural and mechanical) properties of cells and tissues that maintain normal cell behavior (motility, growth, apoptosis), and the critical importance of the ability of cells to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments. Participants will:

• Be consented;
• Be screened for COVID-19, Flu, and/or RSV symptoms according to BAMC's current screening procedures;
• Have study data collected;
• Complete a symptoms questionnaire;
• imPulseTM Una and TOR e-stethoscopes examination will be conducted;
• Participants will be compensated for completing all study requirements. (Active-Duty personnel must complete the study procedures while off-duty in order to receive compensation.)

Conditions

COVID-19; SARS-CoV-2 Virus; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome; Corona Virus Infection; Influenza; RSV Infection

Keywords

COVID-19 diagnostic product, e-stethoscope, military, Flu, RSV, Passive Detection, Level 42

Outcome Measures

Primary Outcomes (4)

• Digital vibroacoustic biomarker diagnostic performance characteristics specific to imPulse™ Una

  Sensitivity, specificity, positive and negative predictive values - of the imPulse™ Una device for point-of-care diagnosis of COVID-19 among symptomatic and asymptomatic COVID-19 carrier versus those not infected compared to gold standard RT-PCR.

  Enrollment through to study completion (min 48hrs through to 24 months)

• imPulse™ Una infrasound-to-ultrasound e-stethoscope device usability

  Critical importance of the ability to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments

  Enrollment through to study completion (min 48hrs through to 24 months)

• imPulse™ TOR infrasound-to-ultrasound e-stethoscope device usability

  Critical importance of the ability to sense and respond to mechanical stresses, which will be operationally critical for assessment of both traumatic and unconventional exposures in austere environments

  Enrollment through to study completion (min 48hrs through to 24 months)

• Digital vibroacoustic biomarker diagnostic performance characteristics specific to imPulse™ TOR

  Sensitivity, specificity, positive and negative predictive values - of the imPulse™ TOR device for point-of-care diagnosis of COVID-19, Flu, and/or RSV among symptomatic and asymptomatic COVID-19, Flu, and/or RSV carrier versus those not infected compared to gold standard RT-PCR.

  Enrollment through to study completion (min 48hrs through to 24 months)

Study Arms (2)

COVID-19, Flu, and/or RSV positive patients

Participants screened with known COVID-19, Flu, and/or RSV positive test results obtained within 48hrs of recruitment.

Device: imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope

COVID-19, Flu, and/or RSV negative patients

Participants screened with known COVID-19, Flu, and/or RSV negative test results obtained within 48hrs of recruitment.

Device: imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope

Interventions

imPulse™ Systems (Una and TOR) infrasound-to-ultrasound e-stethoscope DEVICE

The imPulse™ Systems are an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.

Also known as: imPulse™ Una, e-stethoscope, Passive Detection, imPulse™ TOR

COVID-19, Flu, and/or RSV negative patients; COVID-19, Flu, and/or RSV positive patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asymptomatic and symptomatic individuals age 18 and older undergoing COVID-19, Flu, and/or RSV screening and testing at Brooke Army Medical Center (BAMC), Ft Sam Houston TX, with and without COVID-19, Flu, and/or RSV diagnosis within 48hrs of consent.

You may qualify if:

• Asymptomatic and symptomatic individuals 18 years and older
• Receiving standard COVID-19, Flu, and/or RSV screening and testing at BAMC
• Do not have to be diagnosed with SARS-CoV-19 (COVID-19), Flu, and/or RSV but only be screened
• English Speaking

You may not qualify if:

• Any individual under age of 18
• Anyone unable to comply (or be assisted) with study procedures
• Anyone not able to provide temperature thermal scan, and/or 3-minute vibroacoustic scan

Sponsors & Collaborators

• The Geneva Foundation: lead
• Brooke Army Medical Center: collaborator
• Level 42 AI, Inc.: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (5)

• Clemmons NS, McCormic ZD, Gaydos JC, Hawksworth AW, Jordan NN. Acute Respiratory Disease in US Army Trainees 3 Years after Reintroduction of Adenovirus Vaccine 1. Emerg Infect Dis. 2017 Jan;23(1):95-98. doi: 10.3201/eid2301.161297. Epub 2017 Jan 15.

  PMID: 27748651 BACKGROUND

• Sanchez JL, Cooper MJ, Myers CA, Cummings JF, Vest KG, Russell KL, Sanchez JL, Hiser MJ, Gaydos CA. Respiratory Infections in the U.S. Military: Recent Experience and Control. Clin Microbiol Rev. 2015 Jul;28(3):743-800. doi: 10.1128/CMR.00039-14.

  PMID: 26085551 BACKGROUND

• Armed Forces Health Surveillance Center (AFHSC). Surveillance Snapshot: illness and injury burdens among U.S. military recruit trainees, 2012. MSMR. 2013 Apr;20(4):24. No abstract available.

  PMID: 23617314 BACKGROUND

• Murray CJ, Lopez AD. Measuring the global burden of disease. N Engl J Med. 2013 Aug 1;369(5):448-57. doi: 10.1056/NEJMra1201534. No abstract available.

  PMID: 23902484 BACKGROUND

• Alahi MEE, Mukhopadhyay SC. Detection Methodologies for Pathogen and Toxins: A Review. Sensors (Basel). 2017 Aug 16;17(8):1885. doi: 10.3390/s17081885.

  PMID: 28813028 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Influenza, Human; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections

Study Officials

• Tony T Yuan, PhD

  Uniformed Services University of the Health Sciences (USUHS)

  PRINCIPAL INVESTIGATOR

• Michael Morris, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 13, 2023
• Study Start: May 15, 2023
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)